Acorai Announces First Patient Enrolled in 1,000-Patient HOSP-HF Study

NEW YORK, March 31, 2026 /PRNewswire/ -- Acorai is pleased to announce the enrolment of its first patient in the 1000-patient HOSP-HF study (Hemodynamic Observational Study in Patients with Heart Failure using a Non-Invasive Multi-Modal Sensing Device).

This multi-site observational study will evaluate whether objective, non-invasive congestion assessment during hospitalization and near discharge is associated with 30-day outcomes in decompensated heart failure patients. The study will run across ten centers in Europe, Asia and the United States during 2026.

Addressing a persistent unmet need in discharge readiness

Residual congestion at discharge is recognized as a key driver of early deterioration after heart failure hospitalization. Yet in routine practice, discharge-readiness assessment can be inconsistent and uncertain, relying on a combination of physical examination, natriuretic peptides, daily weight, imaging, and clinical judgment that does not adequately capture hemodynamic change.

What HOSP-HF is evaluating

HOSP-HF is designed to evaluate Acorai's investigational non-invasive bedside device in patients admitted with decompensated heart failure. The study involves daily Acorai recordings during the index hospital stay, including a final recording near discharge. The study is observational and non-interventional. The objective is to assess whether objective congestion assessment during hospitalization and near discharge is associated with better 30-day outcomes and standard care markers of congestion.

"HOSP-HF provides the opportunity to operationalize 'readiness for discharge' in a measurable, reproducible way. By incorporating Acorai's non-invasive congestion assessment at the time of discharge, we can move evidence generation beyond subjective clinical stability and toward objective hemodynamic optimization."

– Andrew J. Sauer, MD, Co-Director, Cardiovascular Research & Clinical Scholars Program, Saint Luke's Mid-America Heart Institute

The HOSP-HF study builds on the results of the CAPTURE-HF study, which demonstrated strong association between Acorai's non-invasive estimates of elevated filling pressures and invasive gold-standard (right heart catheterization) assessments. While CAPTURE-HF established technical and physiological validity of the Acorai device, HOSP-HF is designed to demonstrate potential clinical utility and health economic value – to facilitate regulatory clearance and clinical adoption.

"We look forward to initiating the HOSP-HF trial, which will provide valuable insights into standardized, non-invasive assessment of residual congestion, a clinical challenge that remains a significant concern."

– Oscar Braun, MD, Associate Professor, Skåne University Hospital, Lund, Sweden

The HOSP-HF study expands the company's prospective clinical evidence base in a setting with a clear unmet clinical need, and will explore the potential health economic benefits of improved congestion assessment in reducing avoidable admissions, readmissions, and the overall cost of care.

About Acorai

Acorai is dedicated to advancing non-invasive heart failure care by equipping clinicians with next-generation tools to improve patient outcomes. The company's patented SAVE Sensor System is a pioneering multi-sensor platform designed to non-invasively estimate cardiac filling pressures, enabling more confident decision-making across the care continuum. Acorai has received FDA Breakthrough Device Designation and has studied its platform in over 2,000 patients. Supported by leading medtech investors and strategic partners, Acorai is committed to shaping the future of cardiac care through innovation in non-invasive monitoring.

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SOURCE Acorai